FDA Product Code ODP: Intervertebral Fusion Device With Bone Graft, Cervical

FDA product code ODP covers cervical intervertebral fusion devices with bone graft.

These implants are placed between adjacent cervical vertebrae to restore disc height, maintain cervical alignment, and facilitate interbody fusion of the unstable spinal segment. They are used in anterior cervical discectomy and fusion procedures for the treatment of herniated discs, degenerative disc disease, and cervical myelopathy.

ODP devices are Class II medical devices, regulated under 21 CFR 888.3080 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Vy Spine, LLC, Gbs Commonwealth Co., Ltd. and Innovasis, Inc..